Effectiveness and Acceptability of Insertable Devices for Obstetric Fistula Management

Launched by UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · Jul 1, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at how effective and acceptable two types of insertable devices are for managing urinary incontinence caused by obstetric fistula. An obstetric fistula is a condition that can occur after childbirth, leading to uncontrolled leakage of urine. The trial will compare a simple vaginal cup and a modified version of the cup that connects to a bag for collecting urine. Researchers want to see how well these devices work, how comfortable women are using them, and the costs involved in managing the condition.

To participate in the study, women must be diagnosed with a specific type of fistula and have enough space in their vagina to use the cup. They should be willing to insert and remove the devices themselves and must have not yet undergone successful surgery for their condition. Eligible participants will be women aged 18 and older, who can communicate in English or a local language. Throughout the study, participants will learn how to use the devices and share their experiences, helping researchers understand the best ways to manage this challenging condition.

Gender

FEMALE

Eligibility criteria

• Inclusion criteria:
• • VVF confirmed by dye test and clinical exam at least 3cm from the external urethral orifice (regardless of size), adequate vaginal capacity to accommodate the cup (per physician)
• • Willing to insert and remove cup/cup+
• • Clear understanding of the study procedures
• • Willing to participate fully, not yet been repaired or previously failed surgical repair, at least 6mo post-surgery
• • If previous fistula repair, ≥3mo post-delivery
• • If recent birth, age 18+ or emancipated minor
• • Speak English or local language
• Exclusion criteria:
• • Any rectovaginal fistula
• • Urinary leakage \<6ml over 6 hours
• • Women who are candidates for catheterization who could be healed without surgery will be excluded as they are \<3mo post-delivery.